Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

39

32

39

Product registration—pesticides

286

184

627

Product registration—veterinary medicines

155

141

365

Actives

161

205

234

Permits

106

98

180

Items 8L, 8M, 8P

69

65

18

Technical assessment (Item 25)

4

7

14

Notifiable variations

215

263

49

Import consents

178

145

0

Certificates of export

99

93

19

Total

1312

1233

1545

*See description of application types.

2. Pre-application assistance

In March quarter 2017:

  • 39 applications were received
  • 32 applications were finalised
  • 39 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—March Quarter 2017

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

15

14

3

9

Tier 2 (2 months)

22

15

5

26

Tier 3 (3 months)

0

3

1

3

Pre November 2015*

0

0

0

1

Total

39

32

9

39

* This includes all PAAs received under the previous process.

Pre-application assistance (PAA) is an optional, three tiered, fee-based service provided to applicants to provide them with advice before they submit an application for registration. The timeframe for each tiers is based on the complexity and effort required to provide the assistance.

3. Preliminary assessment

In March quarter 2017:

  • 99 per cent were completed within the 30 day timeframe
  • 564 were received
  • 654 were processed
  • 97 per cent went into evaluation.

3.1. Preliminary assessment—March quarter 2017

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

294

286

2

2

100%

Veterinary medicines

137

116

0

1

96%

Total Products

431

402

2(0.5%)

3(0.7%)

99%

Permits

144

108

0

0

100%

Actives

159

163

0

0

100%

Total

734

673

2(0.3%)

3(0.4%)

99%

Preliminary assessment is an administrative check of all applications received to ensure the information necessary to proceed to a full evaluation is present.  The timeframe for preliminary assessment 30 days from receipt.

4. Applications commenced

In March quarter 2017, 708 applications were commenced

  • 441 for products
  • 161 for actives
  • 106 for permits

 active applications 161, permit applications 106.

5. Applications finalised

In March quarter 2017, 628 applications were finalised

  • 325 for products
  • 205 for actives
  • 98 for permits.

 active applications 205, permit applications 98.

6. Timeframe performance

In March quarter 2017, timeframe performance results product applications were:

  • 30 per cent for pesticide products
  • 58 per cent for veterinary medicines products
  • 95 per cent for actives
  • 62 per cent for permits

 active applications 95%, permit applications 62%.

7. Work in progress

At the end of March quarter 2017, there were:

  • 1406 applications in progress
    • 992 product applications
    • 234 active applications
    • 180 permit applications
    • 73 per cent were within timeframe

 active applications 234, permit applications 180.

 

 active applications 88%, permit applications 57%.

Work in progress is an indicator of the future workload of the APVMA. It is calculated as the number of applications still in evaluation at the end of the quarter.

8. Technical assessment, notifiable variations, holders and nominated agents

In March quarter 2017:

  • 7 technical assessments on data packages were finalised
  • 65 applications to change (or create) a holder or nominated agent (item 8L, 8M, 8P) were finalised
  • 263 minor changes to the details of a registered product, active or label (notifiable variations) were finalised.

8.1. Other regulatory assessments—March Quarter 2017

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

4

7

14

57%

Items 8L, 8M, 8P

69

65

18

66%

Notifiable variations

215

263

49

100%

9. Consents to import

In March quarter 2017, 145 consents to import were issued.

9.1. Import consents—March Quarter 2017

Quarter

Received

Finalised

Issued

In progress

Finalised within timeframe (%)

Sep 16

148

141

132

17

92%

Dec 16

112

115

107

0

96%

Mar 17

178

147

145

0

 

Total

438

403

384 (95%)

0

93%

Consents to import are issued to allow importation—in limited circumstances—of unregistered products or unapproved actives into Australia, when a legitimate reason exists for a person or company to have possession of the chemicals in Australia. There is no statutory timeframe for consents to import—the APVMA seeks to process these within 14 days.

10. Certificates of export

In March quarter 2017, 93 certificates of export were issued.

10.1. Export certificates—March Quarter 2017

Quarter

Received

Issued

Not Issued

In progress

Finalised within timeframe (%)

Sep 16

72

72

0

3

69%

Dec 16

96

95

0

10

87%

Mar 17

99

93

1

19

71%

Total

267

260

1

19

76%

Before accepting exports of a chemical product from Australia many countries require an assurance from the government authority responsible for regulating the product in Australia. This is provided by the APVMA in the form of a certificate of export. There are no statutory timeframes for the APVMA to process these but try to complete them within 20 working days

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